Regulatory and Legal
CDRH’s Guidance Goals for 2017
Dec 29, 2016
Marie Thibault CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year...
Despite Device Industry Pushback, FDA Finalizes Emerging Signals Guidance
Dec 13, 2016
Marie Thibault Almost a year after its draft guidance proposing public notification of emerging signals for postmarket medical devices, FDA is issuing final...
Hearing Aid Debate Reaches Congress
Dec 06, 2016
Marie Thibault U.S. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) recently introduced bipartisan legislation to make some kinds of hearing aids...
U.S. Patients with Large Aortic Valves Get Approved TAVR Option
Oct 26, 2016
Marie Thibault CoreValve Evolut R 34 mm transcatheter aortic valve replacement is now the largest FDA-approved valve size. FDA has approved Medtronic's...
Will CE Mark for Boston Sci's Lotus Edge Impact the TAVR Market?
Sep 20, 2016
Marie Thibault Boston Scientific's Lotus Edge valve has received CE Mark. Lotus Edge, the next-generation transcatheter aortic valve (TAVR) from Boston...
Maker of ROCA Ovarian Cancer Test Suspends U.S. Sales
Sep 13, 2016
Marie Thibault In an update after last week's warning from FDA about ovarian cancer screening tests, Abcodia, which sells the ROCA Test, announced it is...
What's Behind FDA's Warning Against Ovarian Cancer Screening Tests?
Sep 09, 2016
Marie Thibault Earlier detection of cancer is a good thing, right? So why did FDA just warn against ovarian cancer screening tests?  This week, the...
Specific UDI 2018 Deadline Pushed Back
Aug 30, 2016
Marie Thibault Device makers have three more years to meet a particular requirement of the Unique Device Identifier (UDI) rule. FDA has issued final guidance...
Concussion Devices First to Be Cleared in New FDA Category
Aug 23, 2016
Marie Thibault ImPACT and ImPACT Pediatric have been FDA-cleared for use in assessing a person's cognitive function after a suspected concussion or brain...
What an Intermediate-Risk Label Means for Sapien 3
Aug 18, 2016
Marie Thibault FDA has approved Edwards Lifesciences' Sapien 3 THV for use in intermediate-risk aortic stenosis patients. FDA has approved the Sapien 3...